Medline DYNJAAHME12Recalls & reported problems
Medline Industries, Inc. · EXCHANGER,HEAT/MOIST,SM,NO PORT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389120453), received between Feb 20, 2025 and Mar 6, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Infusion or Flow Problem1
Patient problems
- Insufficient Information1
- Respiratory Insufficiency1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED, THE PATIENT'S VENTILATOR ALARMED, THE PATIENT WAS REMOVED FROM THE VENT AND ATTEMPTS WERE MADE TO PROVIDE VENTILATION WITH AN AMBU-BAG. ADDITIONALLY, THE HEAT AND MOISTURE EXCHANGER (HME) WAS REMOVED FROM THE VENT CIRCUIT AND HOOKED TO THE EXPIRATORY FILTER OUTLET ON THE AMBU-BAG, THE OTHER END OF THE HME WAS HOOKED TO THE ENDOTRACHEAL TUBE (ETT) AND THE EXPIRATORY PORT ON THE AMBU-BAG WAS LEFT OPEN; AS A RESULT, THE PATIENT DID NOT RECEIVE THE INTENDED BREATHS. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21542403 ↗InjuryFeb 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORT RECEIVED "THE PATIENTS VENTILATOR STARTED TO ALARM SO THE PATIENT WAS REMOVED FROM THE VENT AND ATTEMPTS WERE MADE TO PROVIDE VENTILATION WITH AN AMBU-BAG."
Patient problems: Respiratory Insufficiency
MAUDE report 21422001 ↗
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- VOCSN V+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit185 reports
- GIBECK IPN043751Teleflex Incorporated · Filter, bacterial, breathing-circuit2 recalls7 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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